Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01928056
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2013-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fasted Conditions
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium 10 mg Tablet (Test, Torrent Pharmaceuticals Ltd., India) Versus Singulair® (Montelukast Sodium) 10 mg Tablet (Reference, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective:
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fasted study.
Study Design:
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fasted study.
Study Design:
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: